December 1, 2025Sara Brenner, M.D., MPHPrincipal Deputy CommissionerU.S. Food and Drug Administration10903 New Hampshire Ave.Silver Spring, MD 20993Submitted ElectronicallyRE: FDA-2025-N-4203 Request ...
In 2005’s “ Why Software Fails ,” in IEEE Spectrum, a seminal article documenting the causes behind large-scale software ...
The AHA provided recommendations to the Food and Drug Administration today in response to a request for information on the measurement and evaluation of artificial intelligence-enabled medical devices ...
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